[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635993":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":266,"collaborators":25,"id":269,"slug":270,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":25,"eligibilityCriteria":274,"healthyVolunteers":271,"sex":275,"minAge":276,"maxAge":25,"enrollmentInfo":277,"targetDuration":280,"studyType":281,"phases":25,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},{"fullName":5,"class":6},"Emory University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Incidence of Target Lesion Failure (TLF)","Incidence of Target Lesion Failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR) will be documented.","At hospital discharge, 30 days, 6 months, and 12 months post-discharge, then yearly up to 5 years post-discharge",{"measure":14,"description":15,"timeFrame":12},"Mortality and Myocardial Infarction","Rates of all-cause mortality, cardiovascular death, and myocardial infarction (target vessel and non-target vessel) will be recorded.",{"measure":17,"description":18,"timeFrame":12},"Number of any repeat Revascularization","Frequency of any repeat revascularization, specifically focusing on clinically driven TLR and clinically driven target vessel revascularization (TVR) will be assessed.",{"measure":20,"description":21,"timeFrame":12},"Incidence of Target Vessel Failure (TVF) and definite\u002Fprobable vessel thrombosis","The incidence of Target Vessel Failure (TVF) and definite\u002Fprobable vessel thrombosis according to Academic Research Consortium (ARC) definitions will be documented.",{"measure":23,"description":24,"timeFrame":12},"Number of bleeding events","The safety profile of post-procedural pharmacotherapy will be evaluated through the collection of bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria.",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","PROSPECTIVE","This database is designed as a prospective, international multi-center registry. The project aims to collect longitudinal data to evaluate the clinical performance of drug-coated balloons (DCB) in adult patients undergoing percutaneous coronary intervention (PCI) for de novo coronary artery disease. Emory will serve as the data coordinating center. All the participating sites will input information into Emory-hosted Redcap database. Data use agreements will be executed between Emory and each participating institution prior to data entry.\n\nAs a prospective registry, all clinical interventions, including the choice of DCB, vessel preparation techniques, and adjunct pharmacotherapy, are performed at the discretion of the treating physician according to the standard of care; no experimental interventions are mandated by this protocol.","The participants are patients undergoing standard-of-care DCB PCI for de novo CAD at participating sites.\n\nEligibility will be determined by trained research personnel via a review of the EMR to ensure patients meet the inclusion criteria.",[32],{"label":33,"type":25,"description":34,"interventionNames":25},"Adults undergoing PCI with drug-coated balloons (DCB) for de novo coronary artery disease","All adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.",[36],{"name":37,"affiliation":5,"role":38},"Pratik Sandesara, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Daniel Gold, MD","CONTACT","314-761-3396","daniel.alexander.gold@emory.edu",[46,60,76,87,93,99,108,121,130,143,155,164,177,189,202,214,227,240,253],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":25},"Banner University Medical Center","NOT_YET_RECRUITING","Phoenix","Arizona","85006","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-112.07404,33.44838,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Holy Cross Health Fort Lauderdale","Fort Lauderdale","Florida","33308",{"type":55,"coordinates":66},[67,68],-80.14338,26.12231,{"lat":68,"lon":67},[71,73],{"name":72,"role":42,"phone":25,"phoneExt":25,"email":25},"Josh 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Hospital","02115",{"type":55,"coordinates":125},[115,116],{"lat":116,"lon":115},[128],{"name":129,"role":42,"phone":25,"phoneExt":25,"email":25},"Kevin Croce",{"facility":131,"status":48,"city":132,"state":133,"zip":134,"country":52,"countryCode":53,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Allina Health Minneapolis Heart Institute","Minneapolis","Minnesota","55407",{"type":55,"coordinates":136},[137,138],-93.26384,44.97997,{"lat":138,"lon":137},[141],{"name":142,"role":42,"phone":25,"phoneExt":25,"email":25},"Manos Brilakis",{"facility":144,"status":48,"city":145,"state":145,"zip":146,"country":52,"countryCode":53,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"The Mount Sinai Hospital","New York","10029",{"type":55,"coordinates":148},[149,150],-74.00597,40.71427,{"lat":150,"lon":149},[153],{"name":154,"role":42,"phone":25,"phoneExt":25,"email":25},"Shamin Sharma",{"facility":156,"status":48,"city":145,"state":145,"zip":157,"country":52,"countryCode":53,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"New York-Presbyterian\u002FWeill Cornell Medical Center","10065",{"type":55,"coordinates":159},[149,150],{"lat":150,"lon":149},[162],{"name":163,"role":42,"phone":25,"phoneExt":25,"email":25},"Jai Khatri",{"facility":165,"status":48,"city":145,"state":145,"zip":166,"country":52,"countryCode":53,"cosmosGeoPoint":167,"geoPoint":169,"contacts":170},"Montefiore Medical Center","10467",{"type":55,"coordinates":168},[149,150],{"lat":150,"lon":149},[171,173,175],{"name":172,"role":42,"phone":25,"phoneExt":25,"email":25},"Azeem Latib",{"name":174,"role":75,"phone":25,"phoneExt":25,"email":25},"Louis Verreault-Julien",{"name":176,"role":75,"phone":25,"phoneExt":25,"email":25},"Pier Pasquale Leone",{"facility":178,"status":48,"city":179,"state":145,"zip":180,"country":52,"countryCode":53,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"St. Francis Hospital & Heart Center","Roslyn","11576",{"type":55,"coordinates":182},[183,184],-73.65096,40.79982,{"lat":184,"lon":183},[187],{"name":188,"role":42,"phone":25,"phoneExt":25,"email":25},"Ziad Ali",{"facility":190,"status":48,"city":191,"state":192,"zip":193,"country":52,"countryCode":53,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Sanger Heart & Vascular Institute","Charlotte","North Carolina","28203",{"type":55,"coordinates":195},[196,197],-80.84313,35.22709,{"lat":197,"lon":196},[200],{"name":201,"role":42,"phone":25,"phoneExt":25,"email":25},"Nyal Borges",{"facility":203,"status":48,"city":204,"state":192,"zip":205,"country":52,"countryCode":53,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Duke University Hospital","Durham","27707",{"type":55,"coordinates":207},[208,209],-78.89862,35.99403,{"lat":209,"lon":208},[212],{"name":213,"role":42,"phone":25,"phoneExt":25,"email":25},"Mariem Sawan",{"facility":215,"status":48,"city":216,"state":217,"zip":218,"country":52,"countryCode":53,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":55,"coordinates":220},[221,222],-81.69541,41.4995,{"lat":222,"lon":221},[225],{"name":226,"role":42,"phone":25,"phoneExt":25,"email":25},"Bernardo Cortese",{"facility":228,"status":48,"city":229,"state":230,"zip":231,"country":52,"countryCode":53,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":55,"coordinates":233},[234,235],-86.78444,36.16589,{"lat":235,"lon":234},[238],{"name":239,"role":42,"phone":25,"phoneExt":25,"email":25},"Leah Raj",{"facility":241,"status":48,"city":242,"state":25,"zip":25,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Universitatsklinikum des Saarlandes","Homberg (Efze)","Germany","DE",{"type":55,"coordinates":246},[247,248],9.40261,51.02994,{"lat":248,"lon":247},[251],{"name":252,"role":42,"phone":25,"phoneExt":25,"email":25},"Bruno Scheller",{"facility":254,"status":48,"city":255,"state":25,"zip":25,"country":256,"countryCode":257,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"University Clinical Centre of Serbia","Belgrade","Serbia","RS",{"type":55,"coordinates":259},[260,261],20.46513,44.80401,{"lat":261,"lon":260},[264],{"name":265,"role":42,"phone":25,"phoneExt":25,"email":25},"Goran Stankovic",{"type":38,"investigatorFullName":267,"investigatorTitle":268,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Pratik Sandesara","Assistant Professor","100635993","andreas-registry-assessment-of-novel-drug-coated-balloon-revascularization-effectiveness-angiographic-outcomes-and-safety-100635993",false,"NCT07559903","ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)","Inclusion Criteria:\n\n* All adult patients (≥ 18 years of age) undergoing PCI for de novo CAD using DCB\n\nExclusion Criteria:\n\n* Patients under the age of 18; PCI procedures without the utilization of DCB; PCI procedures for non de novo lesions","ALL","18 Years",{"count":278,"type":279},5000,"ESTIMATED","5 Years","OBSERVATIONAL","The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.",[284],"Coronary Artery Disease",[286,287,288],"Drug coated balloon","Percutaneous coronary intervention","Target lesion failure","2026-09-30",{"date":291,"type":292},"2026-10-05","ACTUAL",{"date":294,"type":292},"2026-07-01",{"date":296,"type":279},"2031-05",{"name":5,"class":6},19]